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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
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BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR Back to Search Results
Model Number G447
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930)
Event Date 07/31/2023
Event Type  Injury  
Manufacturer Narrative
At this time, no further information is available.Should relevant additional information become available this report will be updated.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) device exhibited infection and hematoma.This device was explanted and a hematoma drainage was performed.No additional adverse patient effects were reported.The device is not expected to be returned for analysis.
 
Manufacturer Narrative
At this time, no further information is available.Should relevant additional information become available this report will be updated.
 
Event Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) device exhibited infection and hematoma.This device was explanted and a hematoma drainage was performed.No additional adverse patient effects were reported.The device is not expected to be returned for analysis.Additional information was received which indicated the device remains in service.No explant procedure was performed at this time.
 
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Brand Name
RESONATE X4 CRT-D
Type of Device
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key17865793
MDR Text Key324866167
Report Number2124215-2023-54672
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P010012/S436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/01/2024
Device Model NumberG447
Device Catalogue NumberG447
Device Lot Number276839
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
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